Answering Your Questions About Our Clinical Trials
Clinical Trial Research
Patients who participate in clinical trials have access to the most advanced, evidence-based and cutting edge of new treatments. Patients reason to choose to join clinical trials vary from a desire to help obtain FDA approval for new and better treatments, a personal lack of response to or inability to afford affective commercially available treatments, and/or a desire to have a higher degree of safety and disease response oversight than is typically available in a routine clinic dermatology setting.
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Specific Clinical Screening (At location) -> based on exclusion / inclusion basis
Ameriderm Research participates in FDA approved IRB approved pharmaceutical and device company sponsored clinical trials in all dermatological conditions including Psoriasis, atopic dermatitis (eczema), rosacea, acne, hidradenitis suppurativa, alopecia, actinic keratosis, basal cell carcinoma, squamous cell carcinoma, melanoma, other skin cancers, warts, as well as cosmetic studies involving lasers, fillers, and neuromuscular agents.
Clinical Trials are conducted under an international agreement of oversight by the US FDA, Canadian FDA and regulatory authorities in the Europe and Japan. The agreement focuses on GCP (good clinical practices) which clarifies that patient safety takes precedence over testing any new drug or device. These agencies oversee the studies internationally. They approve of the protocol and follow the study from conception to completion. IRBs (Institutional Review Boards) known as Ethic Boards outside of the US also approve the design of the study and monitor the studies to confirm safety and other ethical approaches are maintained. The inclusion /exclusion criteria for clinical trials are designed so that those who participate are those in whom participate is appropriately safe and ethical while excluding people for whom participate may not fully meet these criteria. Patients are seen typically more frequently in clinical trials than in clinical practice. At these visits not only is response to treatment assessed, but also ongoing patient safety procedures are performed which may include physical exams, blood tests, and imaging tests
Reasons to participate in clinical trials vary from a desire to help develop new and better treatments, a personal lack of response to or inability to afford affective commercially available treatments, a desire to have a higher degree of safety and disease response oversight than is typically available in a routine clinic dermatology setting
This website has been established by the FDA through a mandate from the US congress to provide information concerning clinical trials in general as well as the specifics of all clinical trials being conducted in the US.
Please call our staff at (386) 523-0768